Dry Eye Disease
Conditions
Keywords
lubricating eye drops, dry eyes, artificial tears
Brief summary
The purpose of this post-market clinical follow-up (PMCF) study is to describe the effectiveness and safety of Tears Naturale® Free and Tears Naturale® II lubricant eye drops in subjects experiencing dry eye (DE) symptoms.
Detailed description
Each subject's participation will last approximately 30 days and include three scheduled visits: a screening/baseline clinic visit on Day 1 (Visit 1), a telephone follow-up visit on Day 15 (-2/+5 days) (Visit 2), and an in-office visit on Day 30 (-2/+5 days) (Visit 3). This study will be conducted in Canada.
Interventions
OTHERTears Naturale Free lubricating eye drops
Commercially available, preservative free, artificial tear product containing dextran 70 and hypromellose. Artificial tear products are designed to relieve dryness and irritation by supplementing and stabilizing the tear film.
OTHERTears Naturale II lubricating eye drops
Commercially available, artificial tear product containing dextran 70 and hypromellose with a gentle preservative for multi-dose use. Artificial tear products are designed to relieve dryness and irritation by supplementing and stabilizing the tear film.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Able to read, understand, and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form in English or French. * Able to attend all study visits as required as per protocol. * Mild to moderate dry eye disease. * Willing to discontinue use of all habitual artificial tear supplements and use only the study device for the entire study duration. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Any known allergic reactions to the study products or its ingredients. * Ocular injury to either eye in the past 3 months prior to screening. * Ocular surgery within the previous 6 months or ocular surgery planned during the study. * Use of any systemic medication known to cause dry eye for less than 1 month before the Screening/Baseline visit. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Impact of Dry Eye on Everyday Life - Symptom Bother Module (IDEEL - SB) Score | Screening/Baseline Visit (Day 1), Day 30 | The IDEEL SB module is a 20-question, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each question, the subject selected a single response for both eyes, where 0="None of the time" (Q1) or "I did not have this symptom/Not Applicable" (Q2-20) to 4="All of the time" (Q1) or "Very Much" (Q2-20). The overall Symptom Bother score is calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25, for an overall resultant score ranging from 0 to 100. Higher scores indicate greater symptom bother. |
Countries
Canada
Contacts
STUDY_DIRECTORClinical Trial Lead, Dry Eye
Alcon Research, LLC
Outcome results
None listed